Orlistat EMA [Design Issues]

posted by Pharma_88 – India, 2020-11-27 13:51 (144 d 23:18 ago) – Posting: # 22089
Views: 418

Dear All,

This is regarding Orlistat for EMA submission. We have US product specific guidance available but I am unable to find EMA guidance (most probably its not there).

My question is whether is it required to add third arm (The reference product at 2 x 60 mg or 120 mg tid) as per US OGD for EMA? whether regualotry will accept this design as per FDA or 2WCO is sufficient (The test & reference product at 60 mg tid as crossover)?

thanks.

Complete thread:

Activity
 Admin contact
21,419 posts in 4,475 threads, 1,510 registered users;
online 15 (0 registered, 15 guests [including 7 identified bots]).
Forum time: Wednesday 14:09 CEST (Europe/Vienna)

In the Middles Ages the lingua franca of science was Latin.
Nowadays the language of science is bad English.    Anonymous

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5